Associate Director, Quality Control

Viridian Therapeutics; Waltham (MA); Hybrid; USD 163,000 - 200,000; Full time

Benefits offered by this job

Competitive pay and stock options

Medical, dental, and vision insurance

401(k) Company Match

Paid vacation and holidays

Job summary

Viridian Therapeutics, based in Waltham, MA, is seeking an Associate Director of Quality Control to lead the QC Analytical team and coordinate with CMOs and CTLs. The role focuses on governance of analytical methods, data integrity, and regulatory readiness for clinical and commercial programs.

You will oversee method lifecycle activities, collaborate across functions, and prepare for IND/BLA submissions while ensuring timely QC deliverables and compliance with global regulations.

Qualifications

• Master’s or equivalent with 8+ years in QC/analytical development.
• Experience with biologics QC method lifecycle (transfer, validation, monitoring).
• Experience with external CMOs/CTLs and contract labs.
• Strong communication skills and regulatory inspection experience.
• Travel up to 10%.

Responsibilities

• Provide strategic leadership to QC Analytical team and external partners.
• Develop specifications, reference standards, reagents per global regs.
• Analyze complex analytical data for stakeholders and leadership.
• Lead method lifecycle management and transfers.
• Support regulatory submissions and inspection readiness.

Skills

QC analytical methods

Statistical analysis

Regulatory inspections experience

Contract labs oversight

Communication skills

Data integrity

Travel up to 10%

Education

Master’s degree

Bachelor’s degree

Tools

HPLC/UPLC

ELISA

Spectroscopy

Data analysis tools (JMP)

Job description

• Location 221 CRESCENT ST STE 103A,Waltham, MA, 02453-3425,United States
• Base Pay $163,000.00 - $200,000.00 / Year
• Job Category Quality
• Employee Type FT Exempt
• Required Degree 4 Year Degree
• Travel 10%

At Viridian, we are focused on developing best-in-class medicines for people living with autoimmune and rare diseases. Leveraging our team’s expertise in antibody discovery and engineering, we have created a robust pipeline of differentiated investigational therapeutic candidates for well-validated targets.

Reporting to the Director, Quality Control Analytical, the Associate Director, Quality Control manage CMO/CTL, review data and prepare CoA. This position works closely with other functions within Viridian and external CMO/CTLs.

This role is based in our Waltham, MA headquarters. Our office-based employees are required to work in the office three (3) days a week.

Responsibilities (including, but not limited to):

• Provide strategic leadership to the QC Analytical team, including oversight of external partners to support all stages of program development
• Develop and evolve phase-appropriate specifications, reference standards, and critical reagents in accordance with global regulatory requirements
• Analyze and communicate complex analytical data to internal stakeholders, senior leadership, and external partners
• Establish priorities, lead cross-functional activities, and ensure timely delivery of QC commitments through effective influence and collaboration
• Lead method lifecycle management for QC owned methods including transfers, validations, performance monitoring, improvements and change impact assessments
• Provide strategic and operational leadership for external CMOs and CTLs supporting analytical testing, stability, and product release activities for clinical-stage biopharmaceutical and combination products, including accountability for performance, quality, timelines, issue resolution, and escalation
• Align technical expectations across internal teams and external partners, review data and deliverables, resolve issues, and drive partner accountability
• Identify and elevate analytical, compliance, or execution risks early, with a recommended path forward
• Lead or support deviation, OOS/OOT investigations, and implement robust rooted cause analysis and corrective actions
• Contribute to CMC regulatory submissions, including IND, BLA, and global filings and regulatory inquiries. Support inspection readiness activities and vendor audits
• Serve as the QC subject matter expert during inspections and regulatory inquiries
• Partner with Quality Assurance, Regulatory Affairs, Manufacturing, and Technical Development to ensure alignment across the product lifecycle

Requirements

• Requires a Master’s degree with 8+ years of relevant experience or a Bachelor’s degree with 10+ years of experience in biopharmaceutical quality control or analytical development.
• Demonstrated experience with QC analytical method lifecycle activities for biologics, including method transfer, validation, performance monitoring, improvement, and expansion to support EU regulatory and market requirements
• Experience working with contract laboratories and external manufacturing partners, including data review, technical issue resolution, and partner oversight
• Experience supporting regulatory inspections and health authority interactions
• Strong technical knowledge of analytical , bioanalytical , and device test methods used for biopharmaceutical and combination products , including ELISA, chromatography (HPLC/UPLC), electrophoresis, spectroscopy, compendial methods , and device functional performance testing
• Experience leading investigations and quality system processes (deviations, OOS, CAPA, change control)
• Proficiency with data analysis tools and statistical methods (e.g., JMP) supporting specification setting and method performance trending and data integrity expectations in regulated environments
• Ability to operate effectively in a dynamic, fast-paced biotechnology environment
• Strong written and verbal communication skills with experience preparing technical and regulatory documentation
• Strong commitment to ethical standards
• Proficiency with Microsoft Office Suite (Word, PowerPoint, Excel, Outlook, SharePoint)
• Ability to travel up to 10%
• The salary range for this position is commensurate with experience

Viridian offers a comprehensive benefits package including:

• Competitive pay and stock options for all employees
• Medical, dental, and vision insurance
• Short- and long-term disability coverage
• Life, Travel and AD&D
• 401(k) Company Match with immediate company vest
• Employee Stock Purchase plan
• Generous vacation plan and paid company holiday shutdowns
• Various fertility, mental, financial, and proactive physical health programs

Viridian Therapeutics, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination, harassment, or retaliation of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by Federal, State, and Local laws. Viridian will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Viridian Therapeutics, Inc participates in E-Verify, the federal program for electronic verification of employment eligibility.